BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 1010243 · Received March 8, 2008

    Report

    Report Number
    MW5005837
    Event Type
    Injury
    Date Received
    March 8, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 8, 2008
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ANGIO-SEAL PLACEMENT INTO FEMORAL ARTERY IN 2008 AFTER CARD CATH. I DID NOT KNOW I RECEIVED A ANGIO SEAL UNTIL I WAS IN RECOVERY AND HANDED A BOOKLET. WENT HOME THAT EVENING, EVERYTHING WAS FINE. THE NEXT EVENING AS I WAS GETTING UNDRESSED TO TAKE A SHOWER, I FELT A POP IN MY GROIN AND SEVERE PAIN DOWN MY RIGHT LEG. A LARGE SWELLING ABOUT THE SIZE OF A GRAPEFRUIT APPEARED WITHIN SECONDS AND I CALLED 911. INFORMED BY RESCUE TEAM THAT I WAS BLEEDING INTERNALLY AND RUSHED TO NEAREST HOSPITAL. TRANSFERRED TO ORIGINAL HOSPITAL NEXT DAY AND COMPRESSION WAS USED TO STOP THE BLEEDING. THIS WAS THE MOST PAINFUL THING I HAVE EVER FELT. I AM 4 WEEKS POST OP AND STILL HAVE DISCOMFORT AND PAIN AND LOTS OF BRUISING. I WOULD NEVER AGAIN ALLOW A ANGIO SEAL TO BE PLACED INTO MY BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL ANGIO-SEAL MGB ST JUDE MEDICAL * 2042412

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| S